Tissue-specific Effects of Insufficient Sleep
1 other identifier
interventional
18
1 country
1
Brief Summary
This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2018
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedNovember 30, 2023
November 1, 2023
6.4 years
February 6, 2018
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.
One week
Secondary Outcomes (5)
Changes in macrovascular function
One week
Changes in microvascular function
One week
Changes in cognitive abilities
One week
Changes in circadian rhythms
One week
Changes in metabolic tissue function
One week
Study Arms (1)
Insufficient sleep
EXPERIMENTALEach participant will receive 4 nights of insufficient sleep.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, lean participants.
- No regular physical activity (\<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
- Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
- Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.
You may not qualify if:
- Current or history of any clinically significant medical, psychiatric, or sleep disorder.
- Use or history of any drugs, medications, supplements, caffeine, and alcohol.
- Current or history of shiftwork in six months prior to laboratory study.
- Travel more than one time zone in three weeks prior to laboratory study.
- Blood donation in the 30 days prior to inpatient study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Josiane L. Broussard, PhD
University of Colorado, Boulder
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2018
First Posted
February 19, 2018
Study Start
February 12, 2018
Primary Completion
June 30, 2024
Study Completion
December 30, 2024
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share